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RAC Drugs > US - Glossary of Terms > Flashcards

US - Glossary of Terms Flashcards

1
Q

30 Day Hold

A

Period between filing an IND and FDA approval to proceed

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2
Q

120 day Safety Report

A

Amendment to NDA containing a safety update due after NDA is filed

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3
Q

180-day Exclusivity

A

Protects ANDA applicant from competition

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4
Q

351(k) Application

A

An abbreviated BLA for biological product demonstrated to be biosimilar

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5
Q

505(b)(2) Application

A

An application using investigations which were not performed by/approved for use by the applicant

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6
Q

Traditional 510(k)

A

Premarket submission demonstrating device safety

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7
Q

Special 510(k)

A

For device modifications (not affecting intended use or technology)

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8
Q

Abbreviated 510(k)

A

Demonstrates conformance with guidance documents

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9
Q

513 (g) Request for Info

A

Request for device classification

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10
Q

515 Program Initiative

A

Facilitates device reclassification action

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11
Q

522 Postmarket Surveillance Studies Program

A

Design, tracking, oversight and review responsibilities for medical device studies

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12
Q

AABB

A

American Association of Blood Banks

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13
Q

ACBTSA

A

Advisory Committee on Blood and Tissue Safety and Availability

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14
Q

Accelerated Approval

A

Allows earlier approval of drugs to treat serious diseases and those with an unmet medical need

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15
Q

Accredited Persons Program

A

Accredits third parties to conduct the primary 510(k) review for devices

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16
Q

ACE

A

Adverse Clinical Event

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17
Q

ACRP

A

Associate for Clinical Research Professionals

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18
Q

ACT

A

Applicable Clinical Trial

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19
Q

Action Letter

A

Letter that informs NDA or BLA sponsor of an agency decision (approvable, not approvable and clinical hold)

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20
Q

ADE

A

Adverse Drug Event (or Experience)

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21
Q

ADME

A

Absorption, Distribution, Metabolism and Excretion

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22
Q

ADR

A

Adverse Drug Reaction

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23
Q

AdvaMed

A

Advanced Medical Technology Association

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24
Q

Advisory Committee

A

Commitee used by FDA to obtain independent expert advise

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25
Q

AFDO

A

Association of Food and Drug Officials

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26
Q

AHRQ

A

Agency for Healthcare Research and Quality

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27
Q

AIA

A

America Invents Act (2011)

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28
Q

AIDC

A

Automatic Identification and Data Capture

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29
Q

AIP

A

Application Integrity Policy (regarding data reliability)

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30
Q

AMS

A

Agricultural Marketing Service

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31
Q

Analyte

A

In a clinical trial, the part of the sample the test is designated to find or measure

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32
Q

ANDA

A

Abbreviated New Drug Application (for generics)

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33
Q

Annual Report

A

Report that includes safety, efficacy, and labeling info, investigation summaries, CMC updates, and unpublished clinical trials

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34
Q

ANPR

A

Advance Notice of Proposed Rulemaking

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35
Q

APhA

A

American Pharmacists Association

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36
Q

APHIS

A

Animal and Plant Health Inspection Service

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37
Q

APLB

A

Advertising and Promotional Labeling branch (CBER)

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38
Q

AQL

A

Acceptable Quality Level

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39
Q

ASTM

A

American Society of Testing and Materials

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40
Q

ASR

A

Analyte Specific Reagent

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41
Q

AUT

A

Actual Use Trials

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42
Q

BA/BE Studies

A

Bioavailability / Bioequivalence studies

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43
Q

Bad Ad Program

A

program to ensure avertisers are truthful and not misleading (CDER’s - OPDP)

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44
Q

BCES

A

Blood Establishment Computer Software

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45
Q

BIMO

A

Bioresearch Monitoring Program

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46
Q

BIO

A

Biotechnology Industry Organization

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47
Q

BLA

A

Biologics License Application

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48
Q

BPCA

A

Best Pharmaceuticals for Children Act (2002)

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49
Q

BPCI Act

A

Biologics Price Competition and Innovation Act (2009)

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50
Q

BPDR

A

Biological Product Deviation Report

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51
Q

BsUFA

A

Biosimilar User Fee Act

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52
Q

CAP

A

Color Additive Petition

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53
Q

CBE-30

A

Changes being effected in 30 days (has potential to affect identity, strength, quality, purity, and potency adversely)

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54
Q

CBER

A

Center for Biologics Evaluation and Research

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55
Q

CBP

A

US Customs and Border Protection

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56
Q

CDER

A

Center for Drug Evaluation and Research

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57
Q

CDRH

A

Center for Devices and Radiological Health

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58
Q

CDx

A

Companion Diagnostic

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59
Q

CF

A

Consent Form (ICF, ICD)- info on risks and benefits (per Declaration of Helsinki)

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60
Q

CFG

A

Certificate to Foreign Government - to prove an exporting product can be legally marketed in the US

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61
Q

CFSAN

A

Center for Food Safety and Applied Nutrition

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62
Q

CH

A

Clinical Hold

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63
Q

CHIP

A

Children’s Healthcare Insurance Program

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64
Q

CHPA

A

Consumer Healthcare Products Association

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65
Q

CIOMS

A

Council for International Organizations of Medical Sciences

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66
Q

CIP

A

Clinical Investigation Plan

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67
Q

Class I Device

A

Low risk device class - requires controls to ensure safety and effectiveness

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68
Q

Class II Device

A

Medium risk device class - requires guidance docs, performance standards, postmarket surveillance

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69
Q

Class III Device

A

High risk device class- requires PMA. Life supporting, pose rise. Requires clinical trials

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70
Q

Clearance

A

Devices that receive marketing permission through the 510(k) process

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71
Q

CLIA

A

Clinical Laboratory Improvement Amendments (1988)

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72
Q

Clinical Hold

A

FDA order to delay proposed clinical investigation or suspend

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73
Q

Clinical Investigator

A

A medical researcher in charge of carrying out of a clinical trial protocol

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74
Q

CLSI

A

Clinical and Laboratory Standards Institute

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75
Q

CME

A

Continuing Medical Education

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76
Q

CMS

A

Centers for Medicare & Medicaid Services

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77
Q

COA

A

Clinical Outcomes Assessment- measures how patients feel or function

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78
Q

COE

A

Certificate of Exportability - issued by FDA to exporter

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79
Q

Common Rule

A

Requires IRB to ensure protocol is sufficient to protect a subject during the study

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80
Q

Consent Decree

A

Action carried out by DOJ. Correct cGMP violations by placing severe restrictions to ensure compliance

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81
Q

COOL

A

Country or Original Labeling

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82
Q

CPG

A

Compliance Policy Guide

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83
Q

CPGM

A

Compliance Program Guidance Manual

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84
Q

CPSC

A

Consumer Product Safety Commission

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85
Q

CRF

A

Case Report Form - data collected in a clinical trial

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86
Q

CR Letter

A

Complete Response letter - FDA dececision on NDA or ANDA

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87
Q

CSO

A

Consumer Safety Officer (Regulatory Project Manager)

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88
Q

CTD

A

Common Technical Document

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89
Q

CTP

A

Center for Tobacco Products

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90
Q

DARRTS

A

Document Archiving, Reporting and Regulatory Tracking System (CDER)

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91
Q

DBSQC

A

Division of Biological Standards and Quality Control (CBER)

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92
Q

DDT

A

Drug Development Tools

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93
Q

Declaration of Helsinki

A

Ethical principles for medical research on human subjects

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94
Q

Default Decree

A

A court order when a seized article is not claimed or defended

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95
Q

De Novo Process

A

Route to market for low-moderate risk devices in Class III

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96
Q

DESI

A

Drug Efficacy Study Implementation

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97
Q

DFUF

A

Device Facility User Fee

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98
Q

DHF

A

Design History File

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99
Q

DHR

A

Device History Record

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100
Q

DIA

A

Drug Information Association

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101
Q

DMC

A

Data Monitoring Committee

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102
Q

DMEPA

A

Division of Medication Error Prevention and Analysis (CDER)

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103
Q

DMPQ

A

Division of Manufacturing and Product Quality (CBER)

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104
Q

DMR

A

Device Master Record

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105
Q

DNCE

A

Division of Nonprescription Clinical Evaluation (CDER)

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106
Q

DNRD

A

Division of Nonprescription Regulation Development (CDER)

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107
Q

DRC

A

Direct Recall Classification Program (CBER)

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108
Q

DRISK

A

Division of Risk Management (CBER)

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109
Q

DRLS

A

Drug Registration and Listing System

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110
Q

Drug Competition Action Plan

A

Resolves regulatory obstacles during generic drug review

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111
Q

“Drug Facts” Label

A

Label for OTC drugs

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112
Q

DQSA

A

Drug Quality and Security Act (“Compounding Quality Act”)

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113
Q

DSHEA

A

Drug Supply Chain Security Act

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114
Q

DSNDCA

A

Dietary Supplement and Nonprescription Drug Consumer Protection Act

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115
Q

DTC

A

Direct to Consumer (advertising)

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116
Q

D-U-N-S

A

Data Universal Numbering System (9 digits by Dun & Bradstreet)

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117
Q

EA

A

Environmental Assessment

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118
Q

EAP

A

Expedited Access Pathway Program - voluntary for devices to address unmet medical needs

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119
Q

eBPDR

A

Electronic Biological Product Deviation Reports

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120
Q

EC

A

European Commission, European Community or Ethics Committee

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121
Q

ECO

A

Emergency Change Order

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122
Q

EFTA

A

European Free Trade Association

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123
Q

EIR

A

Establishment Inspection Report

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124
Q

ETASU

A

Elements to Ensure Safe Use

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125
Q

FAERS

A

FDA Adverse Event Reporting System

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126
Q

FALCPA

A

Food Allergen Labeling and Consumer Protection Act (2004)

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127
Q

FAP

A

Food Additive Petition

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128
Q

FAR

A

Field Alert Report

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129
Q

Fast Track

A

FDA program to facilitate development and NDA review process for treatment of life threatening conditions

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130
Q

FCA

A

False Claims Act

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131
Q

FCS

A

Food Contact Substance

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132
Q

FD&C Act

A

Federal Food, Drug and Cosmetic Act (1938)

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133
Q

FDAAA

A

Food and Drug Administration Amendments Act (1938)

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134
Q

FDA ESG

A

FDA Electronic Submissions Gateway

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135
Q

FDAMA

A

FDA Modernization Act (1997)

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136
Q

FDARA

A

FDA Reauthorization Act (2017)

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137
Q

FDSIA

A

FDA Safety and Innovation Act (2012)

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138
Q

FDLI

A

Food and Drug Law Institute

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139
Q

FIFRA

A

Federal Insecticide, Fungicide, and Rodenticide Act

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140
Q

FIH

A

First in Human study

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141
Q

FPI

A

Full Prescribing Information

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142
Q

FPLA

A

Fair Packaging and Labeling Act

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4
5
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143
Q

FR

A

Federal Register

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144
Q

FSIS

A

Food Safety and Inspection Service

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145
Q

FSMA

A

Food Safety Modernization Act (2011)

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146
Q

FSMP

A

Food for Special Medical Purposes

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147
Q

FURLS

A

FDA Unified Registration and Listing System - medical device distributors

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148
Q

GAIN Act

A

Generating Antibiotic Incentives Now (2011)

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149
Q

GAO

A

Government Accountability Office

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150
Q

GARD

A

National Institute of Health Genetic and Rare Diseases

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151
Q

GE

A

Genetically Engineered

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152
Q

GO

A

Office of Global Regulatory Operations and Policy (CDER)

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153
Q

GPO

A

Government Printing Office and Group Purchasing Organization

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154
Q

GPR

A

General Purpose Reagents

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155
Q

“Grandfathered”

A

approval of drugs marketed prior to 1938 and devices before 1976

156
Q

GRAS(E)

A

General Recognized as Safe (and Effective)

157
Q

GPO

A

Group Purchasing Organization - hospitals formed to offer access to contracts for health supplies

158
Q

GRP

A

Good Review Practice

159
Q

GUIDID

A

Global Unique Device Identification Database

160
Q

HAACP

A

Hazard Analysis and Critical Control Point

161
Q

Hatch-Waxman Act

A

Drug Price Competition and Patent Restoration Act (1984)

162
Q

HCEI

A

Healthcare Economic Information

163
Q

HFAC

A

Health Care Fraud and Abuse Control program

164
Q

HCT/P

A

Human Cells, Tissues and Cellular and Tissue-Based Products

165
Q

HDE

A

Humanitarian Device Exemption

166
Q

HeartNet

A

CDRH adverse event reporting - medical devices

167
Q

HEAT

A

Health Car Fraud and Prevention Enforcement Action Team

168
Q

HHS

A

Department of Health and Human Services

169
Q

HIPPA

A

Health Insurance Portability and Accountability Act (1996) AKA “Privacy Rule”

170
Q

HPCUS

A

Homeopathic Pharmacopeia Convention of the US

171
Q

HPUS

A

Homeopathic Pharmacopeia of the US

172
Q

HUD

A

Humanitarian Use Device

173
Q

IB

A

Investigator’s Brochure

174
Q

IC

A

Informed Coonset

175
Q

ICA

A

Intercenter Agreement

176
Q

ICCBBBA

A

International Council for Commonality in Blood Banking Automation

177
Q

ICH

A

International Counsel on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use

178
Q

ICSR

A

Individual Case Safety Report

179
Q

IDE

A

Investigation Device Exemption

180
Q

IDMC

A

Independent Data Monitoring Committee

181
Q

IID

A

Inactive Ingredient Database

182
Q

IMDRF

A

International Medical Device Regulators Forum

183
Q

Immunogenicity

A

the ability of a substance to provoke an immune response

184
Q

IND

A

Investigational New Drug

185
Q

Informed Amendment

A

IND ends with “000” - indicating amendment number

186
Q

INN

A

International Nonproprietary Names

187
Q

Investigator IND

A

an IND submitted by in individual instead of a manufacturer

188
Q

IOM

A

Investigations Operations Manual (or Institute of Medicine)

189
Q

iPSP

A

Initial Pediatric Study Plan

190
Q

IR Letter

A

a letter FDA sends to request clarification or additional info

191
Q

ISAO

A

Information Sharing Analysis Organization

192
Q

ISI

A

Important Safety Information

193
Q

ISO

A

International Organization for Standardization

194
Q

IUO

A

Investigational Use Only

195
Q

IVD

A

In Vitro Diagnostic

196
Q

LDT

A

Laboratory Developed Test - for diagnostic devices

197
Q

LOA

A

Letter of Authorization

198
Q

Lookback Procedure

A

screened used by blood banks for donors who originally tested negative but are now positive

199
Q

Major Statement

A

advertisement of a prescription drugs most important risks (must be spoken)

200
Q

MAF

A

Device Master File (same as DMF)

201
Q

MAPP

A

Manual of Policies and Procedures (CDER)

202
Q

MAUDE

A

Manufacturer and User Facility Device Experience database (CDRH) - device adverse events

203
Q

MDR

A

Medical Device Reporting

204
Q

MDSAP

A

Medical Device Single Audit Program (FDA) - substitute for routine inspections

205
Q

MDUFA

A

Medical Device User Fee Amendments (2018)

206
Q

MDUFMA

A

Medical Device User Fee Modernization Act (2002)

207
Q

MedDRA

A

Medical Dictionary for Regulatory Activity - standardizing medical terminology

208
Q

MedSun

A

Medical Product Safety Network - adverse event reporting (CDRH)

209
Q

MedWatch

A

program for reporting adverse events

210
Q

MMA

A

Medicare Prescription Drug, Improvement and Modernization Act (2003)

211
Q

MOU

A

Memorandum of Understanding - agreement between FDA and another country for agreement on inspections

212
Q

MRCT

A

Multi-Regional Clinical Trial

213
Q

MTD

A

Maximum Tolerated Dose

214
Q

NAI

A

No Action Indicated - (Most favorable FDA post-inspection classification)

215
Q

NCE

A

New Chemical Entity

216
Q

NCTR

A

National Center for Toxicological Research

217
Q

NDA

A

New Drug Application

218
Q

NDA Nubmber

A

6 digit number assigned to each new drug

219
Q

NDA Field Alert

A

report filed within 3 working days on info regarding failures or contamination

220
Q

NDC

A

National Drug Code (first 5 digits identify establishment, last 5 identify drug name, package size, and drug type)

221
Q

NDIN

A

New Dietary Ingredient Notification

222
Q

NIDPOE

A

Notice of Initiation of Disqualification Proceedings and Opportunity Explain letter

223
Q

NLEA

A

Nutrition Labeling and Education Act (1990)

224
Q

NLM

A

National Library of Medicine

225
Q

NME

A

New Molecular Entity

226
Q

NORD

A

National Organization for Rare Disorders

227
Q

NOV

A

Notice of Violation letter

228
Q

NSE

A

Not Substancially Equivalence - device not qualifying for 510(k)

229
Q

NSR

A

Nonsignificant Risk

230
Q

Nuremberg Code of 1947

A

Ethics for human experiments

231
Q

OAI

A

Official Action Indicated - serious FDA post-inspection classication

232
Q

OBRR

A

Office of Blood Research and Review (CBER)

233
Q

OC

A

Office of the Commissioner (FDA)

234
Q

OCBQ

A

Office of Compliance and Biologics Quality (CBER)

235
Q

OCC

A

Office of the Chief Counsel (FDA)

236
Q

OCE

A

Oncology Center of Excellence

237
Q

OCET

A

Office of Counterterrorism and Emerging Threats (FDA)

238
Q

OCI

A

Office of Criminal Investigation (FDA)

239
Q

OCP

A

Office of Combination Products (FDA)

240
Q

OCTGT

A

Office of Cellular, Tissue and Gene Therapies (CBER)

241
Q

ODA

A

Orphan Drug Act of 1983

242
Q

ODE

A

Office of Device Evaluation (FDA)

243
Q

OECD

A

Organization for Economic Cooperation and Development

244
Q

OFM

A

Office of Financial Management (FDA)

245
Q

OGD

A

Office of Generic Drugs Products (CDER)

246
Q

OIG

A

Office of the Inspector General (FDA)

247
Q

OIP

A

Office of International Programs (FDA)

248
Q

OIR

A

Office of In vitro Diagnostics and Radiological Health

249
Q

OIRA

A

Office of Information and Regulatory Affairs (OMB)

250
Q

OMEPRM

A

Office of Medication Error Prevention and Risk Management (CDER)

251
Q

OND

A

Office of New Drugs (CDER)

252
Q

ONDQA

A

Office of New Drug Quality Assessment (CDER)

253
Q

ONPLDS

A

Office of Nutritional Products, Labeling and Dietary Supplements (CFSAN)

254
Q

OOPD

A

Office of Orphan Products Development (FDA)

255
Q

OPA

A

Office of Public Affairs (FDA)

256
Q

OPDP

A

Office of Prescription Drug Promotion (CDER)

257
Q

Open Label Study

A

clinical trial in which subjects and investigators are aware of the treatment received

258
Q

OPQ

A

Office of Pharmaceutical Quality (CDER)

259
Q

ORA

A

Office of Regulatory Affairs (FDA) - oversees field organization

260
Q

Orange Book

A

FDA published listing of all generic drugs

261
Q

Orphan Drug

A

treats disease affecting less than 200k ppl in US or more than 200k but no recovery of expenses from development

262
Q

OSB

A

Office of Surveillance and Biometrics (CDRH)

263
Q

OSI

A

Office of Scientific Integrity (FDA)

264
Q

OTAT

A

Office of Tissues and Advanced Therapies (CBER)

265
Q

OTC Monograph

A

rules for a number of OTC drug categories

266
Q

OVRR

A

Office of Vaccine Research and Review (CBER)

267
Q

PADER

A

Periodic Adverse Drug Experiences Report

268
Q

PAI

A

Preapproval Inspection

269
Q

PAS

A

Prior Approval Supplement or Postapproval Study

270
Q

PAT

A

Process Analytical Technology

271
Q

PBRER

A

Periodic Benefit-Risk Evaluation reports

272
Q

PCM

A

Payment Confirmation Number

273
Q

PD

A

Pharmacodynamics - study of reactions between drugs and living structures

274
Q

PDA

A

Parenteral Drug Association

275
Q

PDMA

A

Prescription Drug Marketing Act (1987)

276
Q

PDP

A

Product Development Protocol

277
Q

PDUFA

A

Prescription Drug User Fee Act (1992)

278
Q

Pediatric Rule

A

Requires manufacturers to assess safety and effectiveness of certain drugs in pediatric patients

279
Q

PEPFAR

A

Presidents Emergency Plan for AIDS Relief

280
Q

PGx

A

Pharmacogenomics - study of DNA and RNA variations to drug response

281
Q

Pharmacoviligance

A

Adverse event monitoring and reporting

282
Q

phRMA

A

Pharmaceutical Research and Manufacturers of America

283
Q

Phase I

A

first study in humans (few as 10 ppl) usually open-label study. Includes PK, ADME and dose escalation studies

284
Q

Phase II

A

clinical trials of 100-300 who have condition of interest. Includes PK, dose ranging, safety and efficacy

285
Q

Phase III

A

clinical trial of (100s-1000s) safety & efficacy

286
Q

Phase IV

A

Postmarket clinical trials performed to support labeling and advertising or fulfill FDA safety requires notes at the time for NDA approval

287
Q

PHI

A

Protected Health Information

288
Q

PHS

A

Public Health Service

289
Q

PI

A

Package Insert or Principal Investigator

290
Q

PK

A

Pharmacokinetics - study of chemicals and medicines ADME processes

291
Q

PLR

A

Physician Labeling Rule

292
Q

PMA

A

Premarket Approval - marketing application required for Class III devices

293
Q

PMC

A

Postmarketing Commitment - studies a sponsor has agree to conduct but not required by a statute or regulation

294
Q

PMDSIA

A

Pediatric Medical Device Safety and Improvement Act (2007)

295
Q

PMN

A

Premarket Notification aka “510(k)”

296
Q

PMOA

A

Primary Mode of Action

297
Q

PMR

A

Postmarketing Requirments - studies sponsors are required to conduct under a law or regulation

298
Q

PMS

A

Postmarketing Surveillance - monitoring of approved products safety (phase IV studies and AE reporting)

299
Q

PPA

A

Poison Prevention Act

300
Q

PPACA

A

Patient Protection and Affordable Care Act (2010)

301
Q

PPI

A

Patient Package Insert

302
Q

PPSR

A

Proposed Pediatric Study Request

303
Q

PREA

A

Pediatric Research Equity Act (2003)

304
Q

Preclinical Studies

A

Animal PK and toxicity studies (GLP)

305
Q

Pre-Sub Meeting

A

meeting for applicant to get FDA feedback prior to intended submission of an IDE or device marketing application

306
Q

Priority Review

A

drugs appearing to represent an advance over available therapy (NDAs and BLAs review faster than standard applications)

307
Q

PRO

A

Patient Reported Outcome

308
Q

Protocol

A

document describing a clinical trials objectives, design, and methods

309
Q

PTC

A

Points to Consider guidance (CBER)

310
Q

PTCC

A

Pharmacology/Toxicology Coordinating Committee (CDER)

311
Q

PTE

A

Patent Term Extension

312
Q

PTO

A

Patent and Trademark Office

313
Q

Purple Book

A

published list of biological products (licensed by FDA under the PHS Act)

314
Q

QbR

A

Question-based Review (CDER) - CMC evaluation of ANDAs - ensuring generic drug quality

315
Q

QIDP

A

Qualified Infection Disease Product

316
Q

QoL

A

Quality of Life

317
Q

QSIT

A

Quality System Inspection Technique

318
Q

Q-Submission Program

A

provides submitters opportunity to discuss device submissions

319
Q

QSR

A

Quality System Regulation (21 CFR 820) - GMPs for devices

320
Q

Qualified Health Claim

A

food labeling health claim supported by scientific evidence

321
Q

RCDAD

A

Relevant Communicable Disease Agents and Diseases

322
Q

RCT

A

Randomized Clinical Trial

323
Q

Class I Recall

A

recall where device would cause serious adverse health consequences

324
Q

Class II Recall

A

recall where device may cause temporary health consequences

325
Q

Class III Recall

A

recall where device is not likely to cause adverse health consequences

326
Q

Reference Product

A

biological product license under PHS Act section 351(a) against which a product is evaluated in 351(k)

327
Q

REMS

A

Risk Evaluation and Mitigation Strategies

328
Q

RFA

A

Request for Application

329
Q

RFD

A

Request for Designation - from Office of Combination Products (OCP)

330
Q

RFR

A

Request for Reconsideration (OCP)

331
Q

RFR

A

Reportable Food Registry - foods suspected of causing serious adverse health consequences

332
Q

RLD

A

Reference Listed Drug

333
Q

RMAT

A

Regenerative Medicine Advanced Therapy Designation (Same as fast track and Breakthrough)

334
Q

Rolling NDA Submission

A

allows for filing of completed portions of NDA. Only permitted for Fast Track designation

335
Q

RPM

A

Regulatory Procedures Manual

336
Q

RTA Policy

A

Refuse to Accept - FDA checklist to ensure 510(k) or PMA is administratively complete

337
Q

RTF

A

Refusal to File - letter sent by FDA when an incomplete NDA or ANDA is filed. (sent within 60 days)

338
Q

RUO

A

Research Use Only

339
Q

SAHCODHA

A

Severe Adverse Health Consequence or Death in Humans or Animals

340
Q

SBA

A

Summary Basis of Approval

341
Q

SC

A

Study Coordinator

342
Q

SDQA

A

Safe Drinking Water Act

343
Q

Se

A

Substantially Equivalent

344
Q

SECG

A

Small Entity Compliance Guide

345
Q

Sentinel Initiative

A

FDA program to track reports of adverse events

346
Q

SGE

A

Special Government Employee

347
Q

SMDA

A

Safe Medical Devices Act (1990)

348
Q

SoCRA

A

Society of Clinical Research Associates

349
Q

SPA

A

Special Protocol Assessment

350
Q

SPL

A

Structured Product Label

351
Q

SR

A

Significant Risk (device)

352
Q

SSED

A

Summary of Safety and Effectiveness Data (used to approve or deny the PMA)

353
Q

SST

A

Safety Signal Tracking

354
Q

Standard Review

A

FDA review for drug with therapeutic qualities similar to those already approved for marketing

355
Q

Subpart E

A

21 CFR 312 - Accelerated review for life threatening and severely debilitating illness

356
Q

Subpart H

A

21 CFR 314.500 - approval based on a surrogate endpoint or approved with restrictions and or phase IV trials

357
Q

Substantial Equivalence

A

Comparison of a new device to a marketed device (safe and effective as another 510(k)-cleared device)

358
Q

Suitability Petition

A

a request to FDA to submit an ANDA for a drug varying from a Reference Listed Drug

359
Q

SUPAC

A

Scale Up and Post-Approval Changes

360
Q

SUPPORT Act

A

Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities

361
Q

TPP

A

Target Product Profile

362
Q

TEA

A

Time and Extent Application

363
Q

NSE

A

Not Substancially Equivalence - device not qualifying for 510(k)

364
Q

THOMAS

A

Public federal legislation database (Library of Congre

365
Q

NSE

A

Not Substancially Equivalence - device not qualifying for 510(k)

366
Q

TK

A

Toxicokinetics

367
Q

TOPRA

A

The Organization for Professionals in Regulatory Affairs

368
Q

TPLC

A

Total Product Lifecycle

369
Q

tIND

A

allows limited use of an unapproved drug for patients with serious/life-threatening disease

370
Q

TRO

A

Temporary Restraining Order - stops distribution of a product

371
Q

TSCA

A

Toxic Substances Control Act

372
Q

TTB

A

Alcohol and Tobacco Tax and Trade Bureau

373
Q

UADE

A

Unexpected Adverse Device Effect

374
Q

UDI

A

Unique Device Identification

375
Q

Umbrella Policy

A

after a drug is eligable for 5-year NCE exclusivity, certain drug products subsequently developed also benefit form the original products exclusivity

376
Q

USAN

A

US Adopted Name

377
Q

User Fees

A

established by PDUFA

378
Q

VAERS

A

Vaccine Adverse Event Reporting System

379
Q

VAI

A

Voluntary Action Indicated - moderately serious FDA posit-inspection classification

380
Q

NSE

A

Not Substancially Equivalence - device not qualifying for 510(k)

380
Q

STRA

A
381
Q

VSTA

A

Virus-Serum-Toxin Act

382
Q

Warning Letter

A

a FDA violation letter. requires action within 15 years

383
Q

NSE

A

Not Substancially Equivalence - device not qualifying for 510(k)

384
Q

WR

A

Written Request - isued by FDA to allow companies to conduct pediatric studies under 505A of the FD&C Act

RAC Drugs (2 decks)

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